Quality Assurance Manager, Biopharma (JP9806)

3 Key Consulting is hiring a Quality Assurance Manager for a consulting engagement with a leading global biopharmaceutical company. The role will provide quality oversight and guidance regarding the development of process control plans and implementation of process improvements/changes.

Requirements

• Quality Assurance experience
• Experience with technical methods
• Experience with combination products
• BS or BE in Engineering and previous experience in the medical device and/or pharmaceutical industries
• 8 years current experience with engineering processes/procedures and quality tools
• Major contributions to or the leadership of projects from development through the 510k and PMA approval process
• Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification/validation, DOE/SPC process optimization & validation (IQ, OQ, PQ), P/DFMEA
• Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions
• Experience in test or inspection method design and development
• Small scale device assembly and/or benchtop testing experience
• Experience with Automated Test Equipment (ATE)
• Experience regarding Measurement Systems Analysis/GRR principles, including study design/execution/troubleshooting
• Strong critical thinking, problem solving, risk assessment, and risk management skills

Benefits

• Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship
• Four Day Work Week
• Generous Parental Leave
• Tuition Reimbursement
• Relocation Assistance